Methods and systems for programming neuromodulation devices

ABSTRACT

An example of a system for delivering neurostimulation may include a programming control circuit and a user interface. The programming control circuit may be configured to generate stimulation parameters controlling delivery of neurostimulation pulses according to one or more stimulation waveforms associated with areas of stimulation each defined by a set of electrodes. The neurostimulation pulses are each delivered to an area of stimulation. The user interface may include a display screen and an interface control circuit. The interface control circuit may be configured to define the one or more stimulation waveforms and the areas of stimulation, and may include a stimulation frequency module configured to display a stimulation rate table on the display screen. The stimulation rate table may present stimulation frequencies associated with each of the areas of stimulation for selection by a user.

CLAIM OF PRIORITY

This application claims the benefit of priority to U.S. ProvisionalPatent Application Ser. No. 62/273,508, filed on Dec. 31, 2015 and U.S.Provisional Patent Application Ser. No. 62/150,935, filed Apr. 22, 2015,each of which is incorporated herein by reference in its entirety.

TECHNICAL FIELD

This document relates generally to neurostimulation and moreparticularly to a neurostimulation system including various featuresfacilitating programming of stimulation devices for neuromodulation withsafe and efficacious settings.

BACKGROUND

Neurostimulation, also referred to as neuromodulation, has been proposedas a therapy for a number of conditions. Examples of neurostimulationinclude Spinal Cord Stimulation (SCS), Deep Brain Stimulation (DBS),Peripheral Nerve Stimulation (PNS), and Functional ElectricalStimulation (FES). Implantable neurostimulation systems have beenapplied to deliver such a therapy. An implantable neurostimulationsystem may include an implantable neurostimulator, also referred to asan implantable pulse generator (IPG), and one or more implantable leadseach including one or more electrodes. The implantable neurostimulatordelivers neurostimulation energy through one or more electrodes placedon or near a target site in the nervous system. An external programmingdevice is used to program the implantable neurostimulator withstimulation parameters controlling the delivery of the neurostimulationenergy.

In one example, the neurostimulation energy is delivered in the form ofelectrical neurostimulation pulses. The delivery is controlled usingstimulation parameters that specify spatial (where to stimulate),temporal (when to stimulate), and informational (patterns of pulsesdirecting the nervous system to respond as desired) aspects of a patternof neurostimulation pulses. The human nervous systems use neural signalshaving sophisticated patterns to communicate various types ofinformation, including sensations of pain, pressure, temperature, etc.It may interpret an artificial stimulation with a simple pattern ofstimuli as an unnatural phenomenon, and respond with an unintended andundesirable sensation and/or movement. Also, as the condition of thepatient may change while receiving a neurostimulation therapy, thepattern of neurostmulation pulses applied to the patient may need to bechanged to maintain efficacy of the therapy while minimizing theunintended and undesirable sensation and/or movement. While modernelectronics can accommodate the need for generating sophisticated pulsepatterns that emulate natural patterns of neural signals observed in thehuman body, the capability of a neurostimulation system depends on itspost-manufacturing programmability to a great extent. For example, asophisticated pulse pattern may only benefit a patient when it iscustomized for that patient and updated timely in response to changes inthe patient's conditions and needs. This makes programming of astimulation device for a patient a challenging task.

SUMMARY

An example (e.g., “Example 1”) of a system for deliveringneurostimulation to a patient using a plurality of electrodes andcontrolling the delivery of the neurostimulation by a user is provided.The system may include a programming control circuit and a userinterface. The programming control circuit may be configured to generatea plurality of stimulation parameters controlling delivery ofneurostimulation pulses according to one or more stimulation waveformsassociated with a plurality of areas of stimulation each defined by aset of electrodes selected from the plurality of electrodes. Theneurostimulation pulses are each to be delivered to an area ofstimulation of the plurality of areas of stimulation. The user interfacemay include a display screen and an interface control circuit. Theinterface control circuit may be configured to define the one or morestimulation waveforms and the plurality of areas of stimulation, and mayinclude a stimulation frequency module configured to display astimulation rate table on the display screen. The stimulation rate tablemay present a plurality of stimulation frequencies associated with eacharea of the plurality of areas of stimulation. The interface controlcircuit may be configured to receive a selection of a stimulationfrequency from the presented plurality of stimulation frequencies forthat area of the plurality of areas of stimulation.

In Example 2, the subject matter of Example 1 may optionally beconfigured such that the stimulation frequency module is configured toallow the user to select between a single frequency mode and a multiplefrequency mode. The single frequency mode allows for adjustment of thestimulation frequency for an area of the plurality of areas ofstimulation with adjustment of the stimulation frequency for anotherarea of the plurality of areas of stimulation. The multiple frequencymode allows for adjustment of the stimulation frequency for an area ofthe plurality of areas of stimulation without adjustment of thestimulation frequency for another area of the plurality of areas ofstimulation.

In Example 3, the subject matter of Example 2 may optionally beconfigured such that the stimulation frequency module is configured tocompute compatible frequencies for each area of the plurality of areasof stimulation to avoid simultaneous delivery of pulses of theneurostimulation pulses in response to a selection of the multiplefrequency mode.

In Example 4, the subject matter of Example 3 may optionally beconfigured such that the stimulation frequency module is configured toidentify one or more compatible frequencies for each area of theplurality of areas of stimulation from a plurality of predeterminedstimulation frequencies to avoid simultaneous delivery of pulses of theneurostimulation pulses, and to indicate the identified one or morecompatible frequencies in the stimulation rate table.

In Example 5, the subject matter of Example 4 may optionally beconfigured such that the stimulation frequency module is configured topresent the plurality of stimulation frequencies with visual indicationsfor the identified one or more compatible frequencies in the stimulationrate table.

In Example 6, the subject matter of Example 5 may optionally beconfigured such that the stimulation frequency module is configured toallow a selection of a stimulation frequency only from the identifiedone or more compatible frequencies.

In Example 7, the subject matter of Example 5 may optionally beconfigured such that the stimulation frequency module is configured toperform an arbitration for each stimulation frequency of the pluralityof stimulation frequencies that is not identified as one of the one ormore compatible frequencies. The arbitration modifies a time of deliveryof each neurostimulation pulse associated with that stimulationfrequency to avoid the simultaneous delivery of pulses of theneurostimulation pulses.

In Example 8, the subject matter of Example 7 may optionally beconfigured such that the stimulation frequency module is configured topresent the plurality of stimulation frequencies with visual indicationsfor one or more of stimulation frequencies of the plurality ofstimulation frequencies to which the arbitration is performed or adegree to which the arbitration is performed for these stimulationfrequencies.

In Example 9, the subject matter of any one or any combination ofExamples 1-8 may optionally be configured such that the user interfaceincludes a graphical user interface.

In Example 10, the subject matter of any one or any combination ofExamples 1-9 may optionally be configured such that the interfacecontrol circuit further comprises an impedance presentation moduleconfigured to receive values of impedances each between two electrodesof the plurality of electrodes for all of combinations of two electrodesavailable from the plurality of electrodes and display the receivedvalues of impedances on the display screen.

In Example 11, the subject matter of any one or any combination ofExamples 1-10 may optionally be configured such that the interfacecontrol circuit comprises an amplitude assignment module configured toassign pulse amplitudes each to an electrode of a set of electrodesselected from the plurality of electrodes for delivering a pulse of theneurostimulation pulses in terms of absolute values.

In Example 12, the subject matter of any one or any combination ofExamples 1-11 may optionally be configured such that the interfacecontrol circuit comprises a clinical effects map configuration moduleconfigured to configure a clinic effects map indicative of therapeuticeffects and side effects estimated for the one or more stimulationwaveforms.

In Example 13, the subject matter of any one or any combination ofExamples 1-12 may optionally be configured to include an implantablestimulator and an external programming device. The implantablestimulator includes a stimulation output circuit configured to deliverthe neurostimulation pulses and a stimulation control circuit configuredto control the delivery of the neurostimulation pulses using theplurality of stimulation parameters. The external programming device isconfigured to be communicatively coupled to the implantable stimulatorvia a wireless communication link, and includes the programming controlcircuit and the user interface.

In Example 14, the subject matter of Example 13 may optionally beconfigured such that the stimulation output circuit comprises aplurality of timing channels each configured to deliver pulses of theneurostimulation pulses when being programmed to be active and not todeliver pulses of the neurostimulation pulses when being programmed tobe inactive The interface control circuit includes a channel timingmodule configured to identify one or more transition points in the oneor more stimulation waveforms at which a timing channel of the pluralityof timing channels becomes active or becomes inactive and apply aturn-off period during which none of the neurostimulation pulse isdelivered from any active channel of the plurality of timing channels toeach point of the identified one or more transition points, so thatrelative timing between the pulses delivered from channels that remainactive before and after a point of the identified one or more transitionpoints remain unchanged.

In Example 15, the subject matter of any one or any combination ofExamples 13 and 14 may optionally be configured such that the externalprogramming device is configured to transmit patient information to theimplantable stimulator via the wireless communication link, and theimplantable stimulator further comprises an implant storage deviceconfigured to store the received patient information, the patientinformation including portions of the patient's electronic medicalrecords.

An example (e.g., “Example 16”) of a method for deliveringneurostimulation to a patient using a plurality of electrodes is alsoprovided. The method includes displaying a stimulation rate table on adisplay screen of a user interface, the stimulation rate tablepresenting a plurality of stimulation frequencies associated with eacharea of a plurality of areas of stimulation each defined by a set ofelectrodes selected from the plurality of electrodes; receiving aselection of a stimulation frequency from the presented plurality ofstimulation frequencies for each area of the plurality of areas ofstimulation; and generating a plurality of stimulation parameterscontrolling delivery of neurostimulation pulses using the stimulationfrequencies selected for the plurality of areas of stimulation.

In Example 17, the subject matter of Example 16 may optionally includeallowing the user to select between a single frequency mode and amultiple frequency mode using the user interface. The single frequencymode allows for adjustment of the stimulation frequency for an area ofthe plurality of areas of stimulation with adjustment of the stimulationfrequency for another area of the plurality of areas of stimulation. Themultiple frequency mode allows for adjustment of the stimulationfrequency for an area of the plurality of areas of stimulation withoutadjustment of the stimulation frequency for another area of theplurality of areas of stimulation.

In Example 18, the subject matter of Example 17 may optionally includecomputing compatible frequencies for each area of the plurality of areasof stimulation to avoid simultaneous delivery of pulses of theneurostimulation pulses in response to a selection of the multiplefrequency mode.

In Example 19, the subject matter of Example 18 may optionally includeidentifying one or more compatible frequencies for each area of theplurality of areas of stimulation from a plurality of predeterminedstimulation frequencies to avoid simultaneous delivery of pulses of theneurostimulation pulses, and indicating the identified one or morecompatible frequencies in the stimulation rate table.

In Example 20, the subject matter of displaying the stimulation ratetable as found in Example 19 may optionally include presenting theplurality of stimulation frequencies with visual indications for theidentified one or more compatible frequencies.

In Example 21, the subject matter of Example 20 may optionally includeallowing a selection of a stimulation frequency only from the identifiedone or more compatible frequencies.

In Example 22, the subject matter of Example 20 may optionally includeperforming an arbitration for each stimulation frequency of theplurality of stimulation frequencies that is not identified as one ofthe one or more compatible frequencies. The arbitration modifies a timeof delivery of each neurostimulation pulse associated with thatstimulation frequency to avoid the simultaneous delivery of pulses ofthe neurostimulation pulses.

In Example 23, the subject matter of displaying the stimulation ratetable as found in Example 22 may optionally include presenting theplurality of stimulation frequencies with visual indications for eachstimulation frequency to which the arbitration is performed.

In Example 24, the subject matter of generating the plurality ofstimulation parameters table as found in Example 16 may optionallyinclude defining the plurality of areas of stimulation using the userinterface, composing one or more stimulation waveforms associated withthe plurality of areas of stimulation using the user interface, andgenerating the plurality of stimulation parameters based on the one ormore stimulation waveforms.

In Example 25, the subject matter of Example 24 may optionally includetransmitting the plurality of stimulation parameters to an implantablestimulator via a wireless communication link. The implantable stimulatorcoupled to one or more implantable lead including lead electrodes of theplurality of electrodes.

This Summary is an overview of some of the teachings of the presentapplication and not intended to be an exclusive or exhaustive treatmentof the present subject matter. Further details about the present subjectmatter are found in the detailed description and appended claims. Otheraspects of the disclosure will be apparent to persons skilled in the artupon reading and understanding the following detailed description andviewing the drawings that form a part thereof, each of which are not tobe taken in a limiting sense. The scope of the present disclosure isdefined by the appended claims and their legal equivalents.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings illustrate generally, by way of example, variousembodiments discussed in the present document. The drawings are forillustrative purposes only and may not be to scale.

FIG. 1 illustrates an embodiment of a neurostimulation system.

FIG. 2 illustrates an embodiment of a stimulation device and a leadsystem, such as may be implemented in the neurostimulation system ofFIG. 1.

FIG. 3 illustrates an embodiment of a programming device, such as may beimplemented in the neurostimulation system of FIG. 1.

FIG. 4 illustrates an embodiment of an implantable pulse generator (IPG)and an implantable lead system, such as an example implementation of thestimulation device and lead system of FIG. 2.

FIG. 5 illustrates an embodiment of an IPG and an implantable leadsystem, such as the IPG and lead system of FIG. 4, arranged to provideneurostimulation to a patient.

FIG. 6 illustrates an embodiment of portions of a neurostimulationsystem.

FIG. 7 illustrates an embodiment of an implantable stimulator and one ormore leads of an implantable neurostimulation system, such as theimplantable neurostimulation system of FIG. 6.

FIG. 8 illustrates an embodiment of an external programming device of animplantable neurostimulation system, such as the implantableneurostimulation system of FIG. 6.

FIG. 9 illustrates an embodiment of portions of a circuit of a userinterface of a programming device, such as the external programmingdevice of FIG. 8.

FIG. 10 illustrates an embodiment of portions of a screen displayingelectrode impedances.

FIG. 11 illustrates an embodiment of area relative timing in deliveringneurostimulation pulses.

FIG. 12 illustrates an embodiment of portions of a screen displaying aclinical effects map.

FIG. 13 illustrates an embodiment of portions of a screen displaying astimulation rate table.

DETAILED DESCRIPTION

In the following detailed description, reference is made to theaccompanying drawings which form a part hereof, and in which is shown byway of illustration specific embodiments in which the invention may bepracticed. These embodiments are described in sufficient detail toenable those skilled in the art to practice the invention, and it is tobe understood that the embodiments may be combined, or that otherembodiments may be utilized and that structural, logical and electricalchanges may be made without departing from the spirit and scope of thepresent invention. References to “an”, “one”, or “various” embodimentsin this disclosure are not necessarily to the same embodiment, and suchreferences contemplate more than one embodiment. The following detaileddescription provides examples, and the scope of the present invention isdefined by the appended claims and their legal equivalents.

This document discusses, among other things, a neurostimulation systemwith programming rules, user interface, and other features thatfacilitate programming of stimulation devices for deliveringneuromodulation to each patient with safe and efficacious settings. Invarious embodiments, the neurostimulation system can include animplantable device configured to deliver neurostimulation (also referredto as neuromodulation) therapies (such as deep brain stimulation (DBS),spinal cord stimulation (SCS), peripheral nerve stimulation (PNS), andvagus nerve stimulation (VNS)) and one or more external devicesconfigured to program the implantable device for its operations andmonitor the performance of the implantable device. While DBS isdiscussed as a specific example, the present subject matter can also beapplied to facilitate programming of stimulation devices for deliveringvarious types of neurostimulation therapies. In general, various aspectsof the present subject matter as discussed in this document may beapplied to any medical system that delivers electrical stimulation to apatient in various embodiments. It is also to be understood that variousfeatures of the neurostimulation are discussed in this documents asexamples of techniques developed to simplify and/or improve selectedaspects of programming of the stimulation devices, rather than all thefeatures needed for the programming.

FIG. 1 illustrates an embodiment of a neurostimulation system 100.System 100 includes electrodes 106, a stimulation device 104, and aprogramming device 102. Electrodes 106 are configured to be placed on ornear one or more neural targets in a patient. Stimulation device 104 isconfigured to be electrically connected to electrodes 106 and deliverneurostimulation energy, such as in the form of electrical pulses, tothe one or more neural targets though electrodes 106. The delivery ofthe neurostimulation is controlled by using a plurality of stimulationparameters, such as stimulation parameters specifying a pattern of theelectrical pulses and a selection of electrodes through which each ofthe electrical pulses is delivered. In various embodiments, at leastsome parameters of the plurality of stimulation parameters areprogrammable by a user, such as a physician or other caregiver whotreats the patient using system 100. Programming device 102 provides theuser with accessibility to the user-programmable parameters. In variousembodiments, programming device 102 is configured to be communicativelycoupled to stimulation device via a wired or wireless link.

In this document, a “user” includes a physician or other clinician orcaregiver who treats the patient using system 100; a “patient” includesa person who receives or is intended to receive neurostimulationdelivered using system 100. In various embodiments, the patient isallowed to adjust his or her treatment using system 100 to certainextent, such as by adjusting certain therapy parameters and enteringfeedback and clinical effects information.

In various embodiments, programming device 102 includes a user interface110 that allows the user to control the operation of system 100 andmonitor the performance of system 100 as well as conditions of thepatient including responses to the delivery of the neurostimulation. Theuser can control the operation of system 100 by setting and/or adjustingvalues of the user-programmable parameters.

In various embodiments, user interface 110 includes a graphical userinterface (GUI) that allows the user to set and/or adjust the values ofthe user-programmable parameters by creating and/or editing graphicalrepresentations of various waveforms. Such waveforms may include, forexample, a waveform representing a pattern of neurostimulation pulses tobe delivered to the patient as well as individual waveforms that areused as building blocks of the pattern of neurostimulation pulses, suchas the waveform of each pulse in the pattern of neurostimulation pulses.The GUI may also allow the user to set and/or adjust stimulation fieldseach defined by a set of electrodes through which one or moreneurostimulation pulses represented by a waveform are delivered to thepatient. The stimulation fields may each be further defined by thedistribution of the current of each neurostimulation pulse in thewaveform. In various embodiments, neurostimulation pulses for astimulation period (such as the duration of a therapy session) may bedelivered to multiple stimulation fields.

In various embodiments, system 100 can be configured forneurostimulation applications. User interface 110 can be configured toallow the user to control the operation of system 100 forneurostimulation. For example, system 100 as well as user interface 100can be configured for DBS applications. Such DBS configuration includesvarious features that may simplify the task of the user in programmingstimulation device 104 for delivering DBS to the patient, such as thefeatures discussed in this document.

FIG. 2 illustrates an embodiment of a stimulation device 204 and a leadsystem 208, such as may be implemented in neurostimulation system 100.Stimulation device 204 represents an embodiment of stimulation device104 and includes a stimulation output circuit 212 and a stimulationcontrol circuit 214. Stimulation output circuit 212 produces anddelivers neurostimulation pulses. Stimulation control circuit 214controls the delivery of the neurostimulation pulses from stimulationoutput circuit 212 using the plurality of stimulation parameters, whichspecifies a pattern of the neurostimulation pulses. Lead system 208includes one or more leads each configured to be electrically connectedto stimulation device 204 and a plurality of electrodes 206 distributedin the one or more leads. The plurality of electrodes 206 includeselectrode 206-1, electrode 206-2, . . . electrode 206-N, each a singleelectrically conductive contact providing for an electrical interfacebetween stimulation output circuit 212 and tissue of the patient, whereN≧2. The neurostimulation pulses are each delivered from stimulationoutput circuit 212 through a set of electrodes selected from electrodes206. In various embodiments, the neurostimulation pulses may include oneor more individually defined pulses, and the set of electrodes may beindividually definable by the user for each of the individually definedpulses or each of collections of pulse intended to be delivered usingthe same combination of electrodes. In various embodiments, one or moreadditional electrodes 207 (each of which may be referred to as areference electrode) can be electrically connected to stimulation device204, such as one or more electrodes each being a portion of or otherwiseincorporated onto a housing of stimulation device 204. Monopolarstimulation uses a monopolar electrode configuration with one or moreelectrodes selected from electrodes 206 and at least one electrode fromelectrode(s) 207. Bipolar stimulation uses a bipolar electrodeconfiguration with two electrodes selected from electrodes 206 and noneelectrode(s) 207. Multipolar stimulation uses a multipolar electrodeconfiguration with multiple (two or more) electrodes selected fromelectrodes 206 and none of electrode(s) 207.

In various embodiments, the number of leads and the number of electrodeson each lead depend on, for example, the distribution of target(s) ofthe neurostimulation and the need for controlling the distribution ofelectric field at each target. In one embodiment, lead system 208includes 2 leads each having 8 electrodes.

FIG. 3 illustrates an embodiment of a programming device 302, such asmay be implemented in neurostimulation system 100. Programming device302 represents an embodiment of programming device 102 and includes astorage device 318, a programming control circuit 316, and a userinterface 310. Storage device 318 stores one or more stimulationwaveforms each represent a pattern of neurostimulation pulses to bedelivered during a stimulation period. Programming control circuit 316generates the plurality of stimulation parameters that controls thedelivery of the neurostimulation pulses according to at least one of thestored one or more stimulation waveforms. User interface 310 representsan embodiment of user interface 110 and includes neurostimulationmodules 320. In various embodiments, neurostimulation modules 320 areeach configured to support one or more functions that facilitateprogramming of stimulation devices, such as stimulation device 104including its various embodiments as discussed in this document, fordelivering neurostimulation to each patient with safe and efficacioussettings. Examples of such one or more functions are discussed belowwith references to FIG. 9.

In various embodiments, user interface 310 allows for definition of apattern of neurostimulation pulses for delivery during aneurostimulation therapy session by creating and/or adjusting one ormore stimulation waveforms using a graphical method. The definition canalso include definition of one or more stimulation fields eachassociated with one or more pulses in the pattern of neurostimulationpulses. In various embodiments, user interface 310 includes a GUI thatallows the user to define the pattern of neurostimulation pulses andperform other functions using graphical methods. In this document,“neurostimulation programming” can include the definition of the one ormore stimulation waveforms, including the definition of one or morestimulation fields.

In various embodiments, circuits of neurostimulation 100, including itsvarious embodiments discussed in this document, may be implemented usinga combination of hardware and software. For example, the circuit of userinterface 110, stimulation control circuit 214, programming controlcircuit 316, and neurostimulation modules 320, including their variousembodiments discussed in this document, may be implemented using anapplication-specific circuit constructed to perform one or moreparticular functions or a general-purpose circuit programmed to performsuch function(s). Such a general-purpose circuit includes, but is notlimited to, a microprocessor or a portion thereof, a microcontroller orportions thereof, and a programmable logic circuit or a portion thereof.

FIG. 4 illustrates an embodiment of an implantable pulse generator (IPG)404 and an implantable lead system 408. IPG 404 represents an exampleimplementation of stimulation device 204. Lead system 408 represents anexample implementation of lead system 208. As illustrated in FIG. 4, IPG404 that can be coupled to implantable leads 408A and 408B at a proximalend of each lead. The distal end of each lead includes electricalcontacts or electrodes 406 for contacting a tissue site targeted forelectrical neurostimulation. As illustrated in FIG. 1, leads 408A and408B each include 8 electrodes 406 at the distal end. The number andarrangement of leads 408A and 408B and electrodes 406 as shown in FIG. 1are only an example, and other numbers and arrangements are possible. Invarious embodiments, the electrodes are ring electrodes. The implantableleads and electrodes may be configured by shape and size to provideelectrical neurostimulation energy to a neuronal target included in thesubject's brain, or configured to provide electrical neurostimulationenergy to a nerve cell target included in the subject's spinal cord.

FIG. 5 illustrates an embodiment of an IPG 504 and an implantable leadsystem 508 arranged to provide neurostimulation to a patient. An exampleof IPG 504 includes IPG 404. An example of lead system 508 includes oneor more of leads 408A and 408B. In the illustrated embodiment,implantable lead system 508 is arranged to provide Deep BrainStimulation (DBS) to a patient, with the stimulation target beingneuronal tissue in a subdivision of the thalamus of the patient's brain.Other examples of DBS targets include neuronal tissue of the globuspallidus (GPi), the subthalamic nucleus (STN), the pedunculopontinenucleus (PPN), substantia nigra pars reticulate (SNr), cortex, globuspallidus externus (GPe), medial forebrain bundle (MFB), periaquaductalgray (PAG), periventricular gray (PVG), habenula, subgenual cingulate,ventral intermediate nucleus (VIM), anterior nucleus (AN), other nucleiof the thalamus, zona incerta, ventral capsule, ventral striatum,nucleus accumbens, and any white matter tracts connecting these andother structures.

Returning to FIG. 4, the IPG 404 can include a hermetically-sealed IPGcase 422 to house the electronic circuitry of IPG 404. IPG 404 caninclude an electrode 426 formed on IPG case 422. IPG 404 can include anIPG header 424 for coupling the proximal ends of leads 408A and 408B.IPG header 424 may optionally also include an electrode 428. Electrodes426 and/or 428 represent embodiments of electrode(s) 207 and may each bereferred to as a reference electrode. Neurostimulation energy can bedelivered in a monopolar (also referred to as unipolar) mode usingelectrode 426 or electrode 428 and one or more electrodes selected fromelectrodes 406. Neurostimulation energy can be delivered in a bipolarmode using a pair of electrodes of the same lead (lead 408A or lead408B). Neurostimulation energy can be delivered in an extended bipolarmode using one or more electrodes of a lead (e.g., one or moreelectrodes of lead 408A) and one or more electrodes of a different lead(e.g., one or more electrodes of lead 408B).

The electronic circuitry of IPG 404 can include a control circuit thatcontrols delivery of the neurostimulation energy. The control circuitcan include a microprocessor, a digital signal processor, applicationspecific integrated circuit (ASIC), or other type of processor,interpreting or executing instructions included in software or firmware.The neurostimulation energy can be delivered according to specified(e.g., programmed) modulation parameters. Examples of setting modulationparameters can include, among other things, selecting the electrodes orelectrode combinations used in the stimulation, configuring an electrodeor electrodes as the anode or the cathode for the stimulation,specifying the percentage of the neurostimulation provided by anelectrode or electrode combination, and specifying stimulation pulseparameters. Examples of pulse parameters include, among other things,the amplitude of a pulse (specified in current or voltage), pulseduration (e.g., in microseconds), pulse rate (e.g., in pulses persecond), and parameters associated with a pulse train or pattern such asburst rate (e.g., an “on” modulation time followed by an “off”modulation time), amplitudes of pulses in the pulse train, polarity ofthe pulses, etc.

FIG. 6 illustrates an embodiment of portions of a neurostimulationsystem 600. System 600 includes an IPG 604, implantable neurostimulationleads 608A and 608B, an external remote controller (RC) 632, aclinician's programmer (CP) 630, and an external trial modulator (ETM)634. IPG 404 may be electrically coupled to leads 608A and 608B directlyor through percutaneous extension leads 636. ETM 634 may be electricallyconnectable to leads 608A and 608B via one or both of percutaneousextension leads 636 and/or external cable 638. System 600 represents anembodiment of system 100, with IPG 604 representing an embodiment ofstimulation device 104, electrodes 606 of leads 608A and 608Brepresenting electrodes 106, and CP 630, RC 632, and ETM 634collectively representing programming device 102.

ETM 634 may be standalone or incorporated into CP 630. ETM 634 may havesimilar pulse generation circuitry as IPG 604 to deliverneurostimulation energy according to specified modulation parameters asdiscussed above. ETM 634 is an external device that is typically used asa preliminary stimulator after leads 408A and 408B have been implantedand used prior to stimulation with IPG 604 to test the patient'sresponsiveness to the stimulation that is to be provided by IPG 604.Because ETM 634 is external it may be more easily configurable than IPG604.

CP 630 can configure the neurostimulation provided by ETM 634. If ETM634 is not integrated into CP 630, CP 630 may communicate with ETM 634using a wired connection (e.g., over a USB link) or by wirelesstelemetry using a wireless communications link 640. CP 630 alsocommunicates with IPG 604 using a wireless communications link 640.

An example of wireless telemetry is based on inductive coupling betweentwo closely-placed coils using the mutual inductance between thesecoils. This type of telemetry is referred to as inductive telemetry ornear-field telemetry because the coils must typically be closelysituated for obtaining inductively coupled communication. IPG 604 caninclude the first coil and a communication circuit. CP 630 can includeor otherwise electrically connected to the second coil such as in theform of a wand that can be place near IPG 604. Another example ofwireless telemetry includes a far-field telemetry link, also referred toas a radio frequency (RF) telemetry link. A far-field, also referred toas the Fraunhofer zone, refers to the zone in which a component of anelectromagnetic field produced by the transmitting electromagneticradiation source decays substantially proportionally to 1/r, where r isthe distance between an observation point and the radiation source.Accordingly, far-field refers to the zone outside the boundary ofr=λ/2π, where λ is the wavelength of the transmitted electromagneticenergy. In one example, a communication range of an RF telemetry link isat least six feet but can be as long as allowed by the particularcommunication technology. RF antennas can be included, for example, inthe header of IPG 604 and in the housing of CP 630, eliminating the needfor a wand or other means of inductive coupling. An example is such anRF telemetry link is a Bluetooth® wireless link.

CP 630 can be used to set modulation parameters for the neurostimulationafter IPG 604 has been implanted. This allows the neurostimulation to betuned if the requirements for the neurostimulation change afterimplantation. CP 630 can also upload information from IPG 604.

RC 632 also communicates with IPG 604 using a wireless link 340. RC 632may be a communication device used by the user or given to the patient.RC 632 may have reduced programming capability compared to CP 630. Thisallows the user or patient to alter the neurostimulation therapy butdoes not allow the patient full control over the therapy. For example,the patient may be able to increase the amplitude of neurostimulationpulses or change the time that a preprogrammed stimulation pulse trainis applied. RC 632 may be programmed by CP 630. CP 630 may communicatewith the RC 632 using a wired or wireless communications link. In someembodiments, CP 630 is able to program RC 632 when remotely located fromRC 632.

FIG. 7 illustrates an embodiment of implantable stimulator 704 and oneor more leads 708 of an implantable neurostimulation system, such asimplantable system 600. Implantable stimulator 704 represents anembodiment of stimulation device 104 or 204 and may be implemented, forexample, as IPG 604. Lead(s) 708 represents an embodiment of lead system208 and may be implemented, for example, as implantable leads 608A and608B. Lead(s) 708 includes electrodes 706, which represents anembodiment of electrodes 106 or 206 and may be implemented as electrodes606.

Implantable stimulator 704 may include a sensing circuit 742 that isoptional and required only when the stimulator needs a sensingcapability, stimulation output circuit 212, a stimulation controlcircuit 714, an implant storage device 746, an implant telemetry circuit744, a power source 748, and one or more electrodes 707. Sensing circuit742, when included and needed, senses one or more physiological signalsfor purposes of patient monitoring and/or feedback control of theneurostimulation. Examples of the one or more physiological signalsinclude neural and other signals each indicative of a condition of thepatient that is treated by the neurostimulation and/or a response of thepatient to the delivery of the neurostimulation. Stimulation outputcircuit 212 is electrically connected to electrodes 706 through one ormore leads 708 as well as electrodes 707, and delivers each of theneurostimulation pulses through a set of electrodes selected fromelectrodes 706 and electrode(s) 707. Stimulation control circuit 714represents an embodiment of stimulation control circuit 214 and controlsthe delivery of the neurostimulation pulses using the plurality ofstimulation parameters specifying the pattern of neurostimulationpulses. In one embodiment, stimulation control circuit 714 controls thedelivery of the neurostimulation pulses using the one or more sensedphysiological signals. Implant telemetry circuit 744 providesimplantable stimulator 704 with wireless communication with anotherdevice such as CP 630 and RC 632, including receiving values of theplurality of stimulation parameters from the other device. Implantstorage device 746 stores values of the plurality of stimulationparameters. Power source 748 provides implantable stimulator 704 withenergy for its operation. In one embodiment, power source 748 includes abattery. In one embodiment, power source 748 includes a rechargeablebattery and a battery charging circuit for charging the rechargeablebattery. Implant telemetry circuit 744 may also function as a powerreceiver that receives power transmitted from an external device throughan inductive couple. Electrode(s) 707 allow for delivery of theneurostimulation pulses in the monopolar mode. Examples of electrode(s)707 include electrode 426 and electrode 418 in IPG 404 as illustrated inFIG. 4.

In one embodiment, implantable stimulator 704 is used as a masterdatabase. A patient implanted with implantable stimulator 704 (such asmay be implemented as IPG 604) may therefore carry patient informationneeded for his or her medical care when such information is otherwiseunavailable. Implant storage device 746 is configured to store suchpatient information. For example, the patient may be given a new RC 632and/or travel to a new clinic where a new CP 630 is used to communicatewith the device implanted in him or her. The new RC 632 and/or CP 630can communicate with implantable stimulator 704 to retrieve the patientinformation stored in implant storage device 746 through implanttelemetry circuit 744 and wireless communication link 640, and allow forany necessary adjustment of the operation of implantable stimulator 704based on the retrieved patient information. In various embodiments, thepatient information to be stored in implant storage device 746 mayinclude, for example, positions of lead(s) 708 and electrodes 706relative to the patient's anatomy (transformation for fusingcomputerized tomogram (CT) of post-operative lead placement to magneticresonance imaging (MRI) of the brain), clinical effects map data,objective measurements using quantitative assessments of symptoms (forexample using micro-electrode recording, accelerometers, and/or othersensors), and/or any other information considered important or usefulfor providing adequate care for the patient. In various embodiments, thepatient information to be stored in implant storage device 746 mayinclude data transmitted to implantable stimulator 704 for storage aspart of the patient information and data acquired by implantablestimulator 704, such as by using sensing circuit 742.

In various embodiments, sensing circuit 742 (if included), stimulationoutput circuit 212, stimulation control circuit 714, implant telemetrycircuit 744, implant storage device 746, and power source 748 areencapsulated in a hermetically sealed implantable housing or case, andelectrode(s) 707 are formed or otherwise incorporated onto the case. Invarious embodiments, lead(s) 708 are implanted such that electrodes 706are placed on and/or around one or more targets to which theneurostimulation pulses are to be delivered, while implantablestimulator 704 is subcutaneously implanted and connected to lead(s) 708at the time of implantation.

FIG. 8 illustrates an embodiment of an external programming device 802of an implantable neurostimulation system, such as system 600. Externalprogramming device 802 represents an embodiment of programming device102 or 302, and may be implemented, for example, as CP 630 and/or RC632. External programming device 802 includes an external telemetrycircuit 852, an external storage device 818, a programming controlcircuit 816, and a user interface 810.

External telemetry circuit 852 provides external programming device 802with wireless communication with another device such as implantablestimulator 704 via wireless communication link 640, includingtransmitting the plurality of stimulation parameters to implantablestimulator 704 and receiving information including the patient data fromimplantable stimulator 704. In one embodiment, external telemetrycircuit 852 also transmits power to implantable stimulator 704 throughan inductive couple.

In various embodiments, wireless communication link 640 can include aninductive telemetry link (near-field telemetry link) and/or a far-fieldtelemetry link (RF telemetry link). For example, because DBS is oftenindicated for movement disorders which are assessed through patientactivities, gait, balance, etc., allowing patient mobility duringprogramming and assessment is useful. Therefore, when system 600 isintended for applications including DBS, wireless communication link 640includes at least a far-field telemetry link that allows forcommunications between external programming device 802 and implantablestimulator 704 over a relative long distance, such as up to about 20meters. External telemetry circuit 852 and implant telemetry circuit 744each include an antenna and RF circuitry configured to support suchwireless telemetry.

External storage device 818 stores one or more stimulation waveforms fordelivery during a neurostimulation therapy session, such as a DBStherapy session, as well as various parameters and building blocks fordefining one or more waveforms. The one or more stimulation waveformsmay each be associated with one or more stimulation fields and representa pattern of neurostimulation pulses to be delivered to the one or morestimulation field during the neurostimulation therapy session. Invarious embodiments, each of the one or more stimulation waveforms canbe selected for modification by the user and/or for use in programming astimulation device such as implantable stimulator 704 to deliver atherapy. In various embodiments, each waveform in the one or morestimulation waveforms is definable on a pulse-by-pulse basis, andexternal storage device 818 may include a pulse library that stores oneor more individually definable pulse waveforms each defining a pulsetype of one or more pulse types. External storage device 818 also storesone or more individually definable stimulation fields. Each waveform inthe one or more stimulation waveforms is associated with at least onefield of the one or more individually definable stimulation fields. Eachfield of the one or more individually definable stimulation fields isdefined by a set of electrodes through a neurostimulation pulse isdelivered. In various embodiments, each field of the one or moreindividually definable fields is defined by the set of electrodesthrough which the neurostimulation pulse is delivered and a currentdistribution of the neurostimulation pulse over the set of electrodes.In one embodiment, the current distribution is defined by assigning afraction of an overall pulse amplitude to each electrode of the set ofelectrodes. In another embodiment, the current distribution is definedby assigning an amplitude value to each electrode of the set ofelectrodes. For example, the set of electrodes may include 2 electrodesused as the anode and an electrode as the cathode for delivering aneurostimulation pulse having a pulse amplitude of 4 mA. The currentdistribution over the 2 electrodes used as the anode needs to bedefined. In one embodiment, a percentage of the pulse amplitude isassigned to each of the 2 electrodes, such as 75% assigned to electrode1 and 25% to electrode 2. In another embodiment, an amplitude value isassigned to each of the 2 electrodes, such as 3 mA assigned to electrode1 and 1 mA to electrode 2. Control of the current in terms ofpercentages allows precise and consistent distribution of the currentbetween electrodes even as the pulse amplitude is adjusted. It is suitedfor thinking about the problem as steering a stimulation locus, andstimulation changes on multiple contacts simultaneously to move thelocus while holding the stimulation amount constant. Control anddisplaying the total current through each electrode in terms of absolutevalues (e.g. mA) allows precise dosing of current through each specificelectrode. It is suited for changing the current one contact at a time(and allows the user to do so) to shape the stimulation like a piece ofclay (pushing/pulling one spot at a time).

Programming control circuit 816 represents an embodiment of programmingcontrol circuit 316 and generates the plurality of stimulationparameters, which is to be transmitted to implantable stimulator 704,based on the pattern of neurostimulation pulses as represented by one ormore stimulation waveforms. The pattern may be created and/or adjustedby the user using user interface 810 and stored in external storagedevice 818. In various embodiments, programming control circuit 816 cancheck values of the plurality of stimulation parameters against safetyrules to limit these values within constraints of the safety rules. Inone embodiment, the safety rules are heuristic rules.

User interface 810 represents an embodiment of user interface 310 andallows the user to define the pattern of neurostimulation pulses andperform various other monitoring and programming tasks. User interface810 includes a display screen 856, a user input device 858, and aninterface control circuit 854. Display screen 856 may include any typeof interactive or non-interactive screens, and user input device 858 mayinclude any type of user input devices that supports the variousfunctions discussed in this document, such as touchscreen, keyboard,keypad, touchpad, trackball, joystick, and mouse. In one embodiment,user interface 810 includes a GUI with an interactive screen thatdisplays a graphical representation of a stimulation waveform and allowsthe user to adjust the waveform by graphically editing the waveformand/or various building blocks of the waveform. The GUI may also allowthe user to perform any other functions discussed in this document wheregraphical editing is suitable as may be appreciated by those skilled inthe art.

Interface control circuit 854 controls the operation of user interface810 including responding to various inputs received by user input device858 and defining the one or more stimulation waveforms. Interfacecontrol circuit 854 includes neurostimulation modules 320.

In various embodiments, external programming device 802 has operationmodes including a composition mode and a real-time programming mode.Under the composition mode (also known as the pulse pattern compositionmode), user interface 810 is activated, while programming controlcircuit 816 is inactivated. Programming control circuit 816 does notdynamically updates values of the plurality of stimulation parameters inresponse to any change in the one or more stimulation waveforms. Underthe real-time programming mode, both user interface 810 and programmingcontrol circuit 816 are activated. Programming control circuit 816dynamically updates values of the plurality of stimulation parameters inresponse to changes in the set of one or more stimulation waveforms, andtransmits the plurality of stimulation parameters with the updatedvalues to implantable stimulator 704.

FIG. 9 illustrates an embodiment of neurostimulation modules 920, whichrepresent an embodiment of neurostimulation modules 320. In theillustrated embodiment, neurostimulation modules 920 includes anamplitude tracking module 960, an impedance presentation module 961, achannel timing module 962, a patent data module 963, an amplitudeassignment module 964, and a clinical effects map configuration module965. In various embodiments, neurostimulation modules 920 may includeany one or any combination of amplitude tracking module 960, impedancepresentation module 961, channel timing module 962, patent data module963, amplitude assignment module 964, clinical effects map configurationmodule 965, a stimulation frequency module 966, and one or more otherfunctional modules configured to be used in programming a stimulationdevice for neurostimulation. In various embodiments, such modules may beused individually or in any combination to facilitate the process ofdefining the one or more stimulation waveforms, and hence the pluralityof stimulation parameters, that represent the pattern ofneurostimulation pulses to be delivered to the patient during aneurostimulation therapy session.

It is to be understood that while neurostimulation modules 920,including amplitude tracking module 960, impedance presentation module961, channel timing module 962, patient data module 963, amplitudeassignment module 964, and clinical effects map configuration module965, are discussed as part of user interface 810, other portions ofexternal programming device 802 may be configured to perform at leastsome of the functions discussed under neurostimulation modules 920without departing from the scope of the present subject matter. In otherwords, the arrangement of amplitude tracking module 960, impedancepresentation module 961, channel timing module 962, patent data module963, amplitude assignment module 964, and clinical effects mapconfiguration module 965 are illustrated in FIG. 9 by way of example,but not by way of limitation, as in various embodiments, the variousfunctions of these modules may each be partially or wholly performed bya circuit that is not necessarily considered to be part of userinterface 810.

Amplitude tracking module 960 allows the user to set patient-specificminimum and maximum pulse amplitudes for the neurostimulation pulsesusing user interface 810. In one embodiment, a CP, such as CP 630, isconfigured to allow the user to limit the pulse amplitudes each in termsof a percentage increase or decrease from an initial programmedamplitude or in terms of an absolute maximum or minimum value. An RC,such as RC 632, is configured to record the maximum and minimum pulseamplitudes set by the user each as an absolute value (rather than apercentage or other relative value), so that the amplitude limits may bepreserved when the patient adjusts the pulse amplitude using the RC.This is because the pulse amplitude set in the RC may change as thepatient adjusts stimulation within the limits set by the user.

In various embodiments, amplitude tracking module 960 also controlsdisplay of the minimum and maximum pulse amplitudes on display screen856. In various embodiments, the minimum and maximum pulse amplitudesmay be displayed on display screen 856 as markers on a button orcontroller for the pulse amplitude, markers on a clinical effects map,or boundaries on a 3-dimensional representation of the stimulationfield. An example of setting and displaying the minimum and maximumpulse amplitudes is discussed in U.S. Provisional Patent ApplicationSer. No. 62/130,037, entitled “DEEP BRAIN STIMULATION CLINICAL EFFECTSMAP WITH VISUAL INDICATORS FOR PATIENT AMPLITUDE LIMITS”, filed on Mar.9, 2015, assigned to Boston Scientific Neuromodulation Corporation,which is incorporated by reference in its entirety.

Impedance presentation module 961 controls display of variouslead/electrode impedance values on display screen 856. The impedance onan electrode can be measured in operating a neurostimulation system toconfirm device functionality such as proper delivery ofneurostimulation. For example, open-circuit and short-circuit are twodevice failures that can be detected by checking electrode impedance.These two types of failures are best detected using two different kindsof impedance measurement. Open circuits may be more easily detected bymeasuring monopolar impedance (e.g., the impedance between one ofelectrodes 406 and one of electrodes 426 and 428 as illustrated in FIG.4). Short circuits may require measurement of bipolar impedances (e.g.,the impedance between two electrodes of electrodes 406 as illustrated inFIG. 4). Such impedance measurements may be performed, for example, byimplantable stimulator 704 alone or by implantable stimulator 704 andexternal programming device 802. Impedance presentation module 961 canreceive the measured impedance values and arrange these impedance valuesfor display on display screen 856. In various embodiments, impedancepresentation module 961 arranges these impedance values to be displayedin an intuitive and user-friendly way to facilitate the use of suchimpedance values as part of the basis for neurostimulation programming,such as by allowing the user to identify potentially problematicelectrodes and determine a need to replace the problematic lead ordefining the one or more stimulation fields in a way obviating thepotential problem.

FIG. 10 illustrates an embodiment of a portion of display screen 856displaying “N-Polar Impedance”. For the purpose of illustration,impedance measurements for 8 lead electrodes E1-E8 (such as electrodes406 as illustrated in FIG. 4) and an additional electrode (such as oneof electrodes 426 and 428 as illustrated in FIG. 4) are shown. It isnoted that the values as shown in FIG. 10 are arbitrary numbers forillustration purposes only. In the illustrated embodiment, impedances onevery combination of electrodes are measured and displayed in a matrix,with the diagonal of the matrix representing monopolar impedances andthe rest of the matrix representing bipolar impedances on for theelectrodes in that row and column. For example, the monopolar impedancefor electrode E2 is 524Ω, and the bipolar impedance between electrodesE2 and E7 is 702Ω. For the bipolar impedances, only the values above thediagonal is shown as the values below the diagonal are identical (e.g.,bipolar impedance between electrodes E2 and E7 and the bipolar impedancebetween electrodes E7 and E2 are the same impedance). In variousembodiments, the bipolar impedances may be displayed only above thediagonal, only below the diagonal, or for the entire matric (withredundancy). In various other embodiments, the matrix can also displaythe additional electrode (such as one of electrodes 426 and 428 asillustrated in FIG. 4), and the monopolar impedances can be displayed asimpedances each between one of the lead electrodes and the additionalelectrode.

The format of the “N-Polar Impedance” display as shown in FIG. 10 isillustrated by way of example, but not way of limitation. In variousembodiments, impedance presentation module 961 can arrange for displayof impedances for all the combinations of electrodes or selectedcombinations of electrodes. In various embodiments, impedancepresentation module 961 can arrange the impedance values to be displayedin any format that allows visual inspection by the user.

Channel timing module 962 controls area relative timing. Implantablestimulator 704 can deliver the neurostimulation pulses through multipletiming channels. For example, stimulation output circuit 212 can includethe multiple timing channels each to be electrically coupled to one ormore electrodes of electrodes 706. The plurality of stimulationparameters may be set, as desirable, for each timing channel to deliverpulses at a pre-defined rate, such that pulses from different channelsarrive at certain intervals relative to each other. To ensure that theserelative intervals remain constant, channel timing module 962 starts a“turn-off” period for all the active timing channels in response to atiming channel being activated or inactivated, followed by an orderedactivation of each channel. In other words, when delivery of pulses fromone of the timing channels of stimulation output circuit 212 starts orends, the delivery of pulses from all the timing channels of stimulationoutput circuit 212 is to be suspended, for example for the current cycle(with the “cycle” being pre-defined such as by a sequence of pulses fromdifferent timing channels that is to be repeated), and restarts from thenext cycle. This ensures that the relative intervals between the timingchannels do not vary depending on the sequence of activation.

FIG. 11 illustrates an embodiment of area relative timing in deliveringneurostimulation pulses. Illustrated by way of example, but not by wayof limitation, a timing diagram in FIG. 11 shows a segment of a patternof neurostimulation pulses where pulses are first delivered from timingchannels 1-3 (CH1-CH3). Then, timing channel 2 (CH 2) is to beinactivated, and timing channel 4 (CH4) is to be activated. This changeof channel activation triggers the turn-off period as shown in FIG. 11,during which the delivery of pulses are suspended for all the timingchannels. Upon the end of the turn-off channel, the delivery of pulsesis resumed according to the new sequence of activation with timingchannel 2 being inactive and timing channel 4 being active.

In various embodiments, channel timing module 962 can incorporate thearea relative timing, such as discussed above, into the one or morestimulation waveforms that may be defined using user interface 810. Inone embodiment, channel timing module 962 asks the user for whether toapply the area relative timing to one or more stimulation waveformsbeing defined using user interface 810, such as by presenting a messagewith an answering field on display screen 856. When the area relativetiming is to be applied, channel timing module 962 identifies one ormore transition points that meet specified criteria for applying thearea relative timing (e.g., points of channel activation orinactivation) in the one or more stimulation waveforms and introducesthe turn-off period to each point of the identified transition points.In another embodiment, channel timing module 962 automatically appliesthe area relative timing to all the stimulation waveforms forneurostimulation without necessarily checking with the user.

Patient data module 963 allows the user to access the patientinformation stored in implantable stimulator 704 using user interface810. In various embodiments, patient data module 963 can allow the userto view the patient information stored in implant storage device 746. Invarious embodiments, patient data module 963 can also allow the user tomake addition to, deletion from, and/or modification of the patientinformation stored in implant storage device 746 upon authorization (forexample as obtained using a pre-authorized username and password). Invarious embodiments, this allows external programming device (such asmay be implemented as CP 630) to be used in a way similar to a computerconfigured as a terminal for an electronic medical record system such asused in a hospital of clinic. In various embodiments, patient datamodule 963 allows the user to obtain information necessary or desirablefor neurostimulation programming.

In one embodiment, patient data module 963 can present a menu listingcategories and/or titles of contents of the patient information storedin implantable stimulator 704. Examples of categories include generalinformation such as patient demographics and general medical history aswell as information specific to the indications for DBS such as brainimages, clinical effect maps, and data of quantitative measurementsspecific to the indications for neurostimulation.

Amplitude assignment module 964 allows the user to assign, using userinterface 810, an amplitude value to each electrode used for deliveringa neurostimulation pulse in the process of defining the one or morestimulation fields, thereby controlling current steering. When aneurostimulation pulse is delivered through multiple electrodesfunctioning as an anode or cathode for that pulse, the currentdistribution needs to be specified for each of the multiple electrodesas part of the definition of the stimulation field. In one embodiment, asingle pulse amplitude is specified for the neurostimulation pulse, andamplitude assignment module 964 allows that pulse amplitude to befractionally assigned to the multiple electrodes, such as a percentagefor each electrode of the multiple electrodes. In another embodiment,which may be referred to as a “milliamp mode”, amplitude assignmentmodule 964 allows an absolute amplitude value to be independentlyassigned to each electrode of the multiple electrodes.

Clinical effects map configuration module 965 receives a selection of atarget for the neurostimulation (such as DBS) and/or an indication forthe neurostimulation (such as a disease known as being treatable byDBS), and automatically configures a clinical effects map based on theselection. The clinical effects map indicates efficacy and side effectsof DBS. In various embodiments, because different indications (e.g.,neuropsychiatric indications) may be associated with symptoms differentthan movement disorders, clinical effects map configuration module 965automatically configures the list of therapeutic effects based on theselected indication. Because side effects are a function of unwantedstimulation of nearby structures, which will vary depending on theanatomical location of the target for DBS, clinical effects mapconfiguration module 965 automatically configures the side effect listbased on the selected indication or target.

FIG. 12 illustrates an embodiment of portions of display screen 856displaying an example of such a clinical effects map 1270. An example ofproducing and visually presenting a clinical effects map such as map1270 is discussed in U.S. Patent Application Publication No. US2014/0066999 A1, entitled “CAPTURE AND VISUALIZATION OF CLINICAL EFFECTSDATA IN RELATION TO A LEAD AND/OR LOCUS OF STIMULATION”, filed on Aug.28, 2013, assigned to Boston Scientific Neuromodulation Corporation,which is incorporated by reference in its entirety. In FIG. 12, a modelof a lead 1208 with electrodes 1206 is displayed, and maps showingvolume of activations are displayed overlaid on the model of the lead.Therapeutic efficacy and adverse side-effects of stimulations areevaluated for a plurality of points about lead 1208 based on clinicaldata resulting from the stimulations to estimate the volume ofactivation for the stimulations. Clinical effects map as shown in FIG.12 is a combination of maps each associated with one of the therapeuticeffects or side effects. In various embodiments, the map for eachtherapeutic or side effect may also be individually displayed.

In various embodiments, clinical effects map configuration module 965may be configured to display one or more clinical effects maps in anyformat that is suitable for indicating efficacy and side effects of DBSto the user for DBS programming, with clinical effects map 1270illustrated in FIG. 12 as one example. In some embodiments, clinicaleffects map configuration module 965 allows the user to select a formatof clinical effects map for display on display screen 856 from aplurality of formats. In various embodiments, the clinical effects mapis indicative of therapeutic and side effects of DBS with respect toeach of various stimulation parameters and stimulation fields based onwhich the user can determine values for the stimulation parameters andselections of electrodes for maximizing therapeutic effects whileminimizing side effects.

Stimulation frequency module 966 allows the user to control stimulationfrequency (also referred to as rate) at which the neurostimulationpulses are delivered. In various embodiments, stimulation frequencymodule 966 allows the user to select between a single frequency mode anda multiple frequency mode. Under the single frequency mode, anadjustment of stimulation frequency in one area of stimulation (e.g.,one stimulation field) causes an equivalent change in the stimulationfrequency in all the areas of stimulation (e.g., all the stimulationfields) in a neurostimulation session, such that only one stimulationfrequency is used at a time. Under the multiple frequency mode, anadjustment of stimulation frequency in one area of stimulation (e.g.,one stimulation field) affects the stimulation frequency associated withthat area only and does not cause change in the stimulation frequencyfor another area (e.g., another stimulation field) in a neurostimulationtherapy session. In various embodiments that use multiple areas ofstimulations in a neurostimulation therapy session, stimulationfrequency module 966 computes compatible rates for each area ofstimulation and displays them in one or more stimulation rate tables ondisplay screen 856. The compatible (or available) rates for an area ofstimulation are stimulation frequencies available for use based on theneurostimulation pulses delivered to all the areas of stimulation. Theincompatible (or unavailable) rates may also be displayed, but are notselectable for use. An example of the incompatible rates includesstimulation frequencies at which two or more pulses of theneurostimulation pulses will be delivered to different areas ofstimulation simultaneously (i.e., at least partially overlapping intime). Simultaneous delivery of stimulation pulses may decreasetherapeutic effectiveness of the neurostimulation.

FIG. 13 illustrates an embodiment of portions of display screen 856displaying an example of such a stimulation rate table (also referred toas stimulation frequency table) 1372. Stimulation rate table 1372presents stimulation frequencies (i.e., rates) for an area ofstimulation. In various embodiments, stimulation frequency module 966limits the stimulation frequencies according to a cumulative rate perlead rule. Under the cumulative rate per lead rule, the user can selectany stimulation frequency (i.e., rate) for the areas of stimulation(field) corresponding to a given lead such that the sum of thestimulation frequencies associated with that lead is below a threshold,which may be specified based on safety considerations. An example of thethreshold is about 255 Hz. In various embodiments, the threshold may bedetermined based on data from safety studies. In various otherembodiments, the cumulative rate (sum of the stimulation frequencies)may be limited for each electrode or a set of electrodes.

When operating in the multiple frequency mode, it is desirable toprevent pulses from different timing channels from being deliveredsimultaneously (such that two or more pulses overlap in time). In oneembodiment, stimulation frequency module 966 provides for (1) alimitation option, in which the available combinations of stimulationfrequencies are limited, or (2) an arbitration option, in which timingof delivery of neurostimulation pulses from a timing channel can beslightly modified (e.g., delayed) when needed, introducing somevariability in the inter-pulse interval (IPI) for that timing channel.In one embodiment, stimulation frequency module 966 allows the user toselect between the limiting and arbitration options, i.e., (1) and (2).When the arbitration option is selected, stimulation frequency module966 causes the degree of the variability in IPI for any combination ofstimulation frequencies on display screen 856 as a percentage of thestimulation pulses that are delayed, as a standard deviation in the IPI,and/or through other descriptive statistics.

In the illustrated embodiment, stimulation rate table 1372 includes allthe stimulation frequencies, with each of the stimulation frequenciesindicated to be (a) selected, (b) available for selection (compatible),or (c) unavailable for selection (incompatible) or available forselection after arbitration. Examples for (a), (b), and (c) areillustrated in FIG. 13 as displaying areas 1374, 1376, and 1378,respectively, in which each stimulation frequency is indicated to be oneof (a), (b), or (c) using gray scale. In other embodiments, eachstimulation frequency may be indicated to be one of (a), (b), or (c)using color, pattern, or any other visually distinguishable features. Ifthe user selects the limitation option, the stimulation frequenciesindicated to be (c), e.g., 1378, are displayed but not selectable by theuser. If the user selects the arbitration option, the stimulationfrequencies indicated to be (c), e.g., 1378, as displayed are eachselectable by the user but associated with a modification of timing(e.g., introduction of delays) in delivering the neurostimulation pulsesresulting from the arbitration. In various embodiments, stimulationfrequency module 966 causes the plurality of stimulation frequencies tobe displayed on screen 856 with each stimulation frequency visuallyindicated to be (a), (b), or (c). When the arbitration option isselected, stimulation frequency module 966 causes the plurality ofstimulation frequencies to be displayed on screen 856 with visualindications for the stimulation frequencies to which the arbitration isperformed and/or the degree to which arbitration is performed for thatcombination of stimulation frequencies.

In one embodiment, stimulation rate table 1372 allows for selection ofall stimulation frequencies, including stimulation frequencies for whichthe arbitration is performed. No stimulation frequency is unavailable instimulation rate table 1372 (i.e., all the stimulation frequencies areselectable), but the stimulation frequencies for which the arbitrationis performed are indicated in stimulation rate table 1372. In oneembodiment, the stimulation frequencies for which the arbitration isperformed are indicated with showing of the degree of resultingvariability in the IPI in stimulation rate table 1372.

In various embodiments, using stimulation rate table 1372 allows theuser to skip directly to desired stimulation frequencies without havingto pass through unwanted combinations of frequencies. Stimulation ratetable 1372 also allows the user to compare a complete list of availablecombinations of the stimulation frequencies before choosing the bestcombination.

In various embodiments, neurostimulation modules 920 may include any oneor any combination of the functional modules discussed above and/or oneor more other functional modules configured to be used in programming astimulation device for neurostimulation. In addition to the Examples1-25 discussed in the Summary Section above, some other non-limitingexamples are provided as follows.

An example (e.g., “Example 26”) of a system for deliveringneurostimulation pulses to a patient using a plurality of electrodes andcontrolling the delivery of the neurostimulation pulses by a user mayinclude a programming control circuit and a user interface. Theprogramming control circuit may be configured to generate a plurality ofstimulation parameters controlling delivery of neurostimulation pulsesaccording to one or more stimulation waveforms. The interface mayinclude a display screen and an interface control circuit. The interfacecontrol circuit may be configured to define the one or more stimulationwaveforms, and may include an impedance presentation module. Theimpedance presentation module may be configured to receive values ofimpedances each between two electrodes of the plurality of electrodesfor all of combinations of two electrodes available from the pluralityof electrodes and display the received values of impedances on thedisplay screen.

In Example 27, the subject matter of Example 26 may optionally beconfigured to further include an implantable stimulator and animplantable lead. The implantable stimulator may include a stimulationoutput circuit configured to deliver the neurostimulation pulses and astimulation control circuit configured to control the delivery of theneurostimulation pulses using the plurality of stimulation parameters.The implantable lead may be configured to be connected to theimplantable stimulator and include a plurality of lead electrodes of theplurality of electrodes.

In Example 28, the subject matter of Example 27 may optionally beconfigured such that the implantable stimulator further includes areference electrode of the plurality of electrodes, and the impedancepresentation module is configured to receive and display values ofmonopolar impedances each between an electrode of the plurality of leadelectrodes and the reference electrode and values of bipolar impedanceseach between two electrodes of the plurality of lead impedances.

In Example 29, the subject matter of Example 28 may optionally beconfigured such that the impedance presentation module is configureddisplay the received values of impedances on the display screen in amatrix showing all the monopolar impedances and bipolar impedances withthe monopolar impedances shown along the diagonal of the matrix.

In Example 30, the subject matter of any one or any combination ofExamples 27-29 may optionally be configured such that the stimulationoutput circuit includes a plurality of timing channels each configuredto deliver pulses of the neurostimulation pulses when being programmedto be active and not to deliver pulses of the neurostimulation pulseswhen being programmed to be inactive, and the interface control circuitincludes a channel timing module configured to identify one or moretransition points in the one or more stimulation waveforms at which atiming channel of the plurality of timing channels becomes active orbecomes inactive and apply a turn-off period during which none of theneurostimulation pulse is delivered from any active channel of theplurality of timing channels to each point of the identified one or moretransition points, so that relative timing between the pulses deliveredfrom channels that remain active before and after a point of theidentified one or more transition points remain unchanged.

In Example 31, the subject matter of any one or any combination ofExamples 27-29 may optionally be configured to further include anexternal programming device configured to be communicatively coupled tothe implantable stimulator via telemetry. The external programmingdevice includes the programming control circuit and the user interface.

In Example 32, the subject matter of Example 31 may optionally beconfigured such that the external programming device is configured to becommunicatively coupled to the implantable stimulator via a wirelesscommunication link using far-field radio frequency telemetry.

In Example 33, the subject matter of any one or any combination ofExamples 31 and 32 may optionally be configured such that the externalprogramming device is configured to transmit patient information to theimplantable stimulator via the wireless communication link, and theimplantable stimulator further includes an implant storage deviceconfigured to store the received patient information, the patientinformation including portions of the patient's electronic medicalrecords.

In Example 34, the subject matter of Example 33 may optionally beconfigured such that the implantable stimulator is configured to producedata to add to the patient information stored in the implant storagedevice.

In Example 35, the subject matter of Example 33 may optionally beconfigured such that the interface control circuit includes a patientdata module configured to allow the user to retrieve the patientinformation from the implantable stimulator using the user interface.The patient data module may be configured to allow the user to selectportions of the patient information for presentation using the displayscreen.

In Example 36, the subject matter of any one or any combination ofExamples 26-35 may optionally be configured such that the interfacecontrol circuit includes an amplitude assignment module configured toassign pulse amplitudes each to an electrode of a set of electrodesselected from the plurality of electrodes for delivering a pulse of theneurostimulation pulses in terms of absolute values.

In Example 37, the subject matter of any one or any combination ofExamples 26-36 may optionally be configured such that the interfacecontrol circuit includes a clinical effects map configuration moduleconfigured to configure a clinic effects map indicative of therapeuticeffects and side effects estimated for the one or more stimulationwaveforms.

In Example 38, the subject matter of Example 37 may optionally beconfigured such that the clinical effects map configuration module isconfigured to receive a selection of an indication for neurostimulationand automatically update the therapeutic effects based on the selectedindication.

In Example 39, the subject matter of Example 37 may optionally beconfigured such that the clinical effects map configuration module isconfigured to receive a selection of a target for neurostimulation or aselection of an indication for the neurostimulation and automaticallyupdate the side effects based on the selected target or the selectedindication.

In Example 40, the subject matter of any one or any combination ofExamples 26-35 may optionally be configured such that the interfacecontrol circuit includes an amplitude tracking module configured toallow the user to set minimum and maximum pulse amplitudes for theneurostimulation pulses using the user interface.

An example (e.g., Example 41”) of a method for programming animplantable stimulator to deliver neurostimulation pulses to a patientusing a plurality of electrodes is also provided. The method includesprogramming an implantable stimulator for delivering electrical pulsesthrough a plurality of electrodes using an external programming device,and presenting information for the programming using the user interfaceof the external programming device. The presentation of the informationincludes displaying values of impedances each between two electrodes ofthe plurality of electrodes for all of combinations of two electrodesavailable from the plurality of electrodes and displaying the receivedvalues of impedances on the display screen.

In Example 42, the subject matter of Example 41 may optionally includedelivering the electrical pulses using a plurality of timing channels ofthe implantable stimulator, the plurality of timing channels eachconfigured to deliver one or more of the electrical pulses when beingprogrammed to be active and none of the electrical pulses when beingprogrammed to be inactive, identifying one or more transition points inthe one or more stimulation waveforms at which a timing channel of theplurality of timing channels becomes active or becomes inactive, andapplying a turn-off period during which none of the electrical pulse isdelivered from any active channel of the plurality of timing channels toeach point of the identified one or more transition points, so thatrelative timing between the pulses delivered from channels that remainactive before and after a point of the identified one or more transitionpoints remain unchanged.

In Example 43, the subject matter of any one or any combination ofExamples 41 and 42 may optionally include providing for wirelesscommunication between the implantable stimulation and the externalprogramming device using far-field radio frequency telemetry.

In Example 44, the subject matter of any one or any combination ofExamples 41-43 may optionally include transmitting patient informationto the implantable stimulator via the wireless communication link andstoring the received patient information in a storage device in theimplantable stimulator. The patient information includes portions of thepatient's electronic medical records including information specific toindications for neurostimulation.

In Example 45, the subject matter of any one or any combination ofExamples 41-44 may optionally include assigning pulse amplitudes each toan electrode of a set of electrodes selected from the plurality ofelectrodes for delivering a pulse of the electrical pulses in terms ofabsolute values.

In Example 46, the subject matter of any one or any combination ofExamples 41-44 may optionally include automatically configuring a cliniceffects map indicative of therapeutic effects and side effects estimatedfor the one or more stimulation waveforms based on a selection of atarget for neurostimulation or a selection of an indication for theneurostimulation.

It is to be understood that the above detailed description is intendedto be illustrative, and not restrictive. Other embodiments will beapparent to those of skill in the art upon reading and understanding theabove description. The scope of the invention should, therefore, bedetermined with reference to the appended claims, along with the fullscope of equivalents to which such claims are entitled.

What is claimed is:
 1. A system for delivering neurostimulation to apatient using a plurality of electrodes and controlling the delivery ofthe neurostimulation by a user, the system comprising: a programmingcontrol circuit configured to generate a plurality of stimulationparameters controlling delivery of neurostimulation pulses according toone or more stimulation waveforms associated with a plurality of areasof stimulation each defined by a set of electrodes selected from theplurality of electrodes, the neurostimulation pulses each to bedelivered to an area of stimulation of the plurality of areas ofstimulation; and a user interface including: a display screen; and aninterface control circuit configured to define the one or morestimulation waveforms and the plurality of areas of stimulation, theinterface control circuit including a stimulation frequency moduleconfigured to display a stimulation rate table on the display screen,the stimulation rate table presenting a plurality of stimulationfrequencies associated with each area of the plurality of areas ofstimulation, configured to receive a selection of a stimulationfrequency from the presented plurality of stimulation frequencies forthat area of the plurality of areas of stimulation, and configured toallow the user to select between a single frequency mode and a multiplefrequency mode, the single frequency mode allowing for adjustment of thestimulation frequency for an area of the plurality of areas ofstimulation with adjustment of the stimulation frequency for anotherarea of the plurality of areas of stimulation, the multiple frequencymode allowing for adjustment of the stimulation frequency for an area ofthe plurality of areas of stimulation without adjustment of thestimulation frequency for another area of the plurality of areas ofstimulation.
 2. The system of claim 1, wherein the stimulation frequencymodule is configured to compute compatible frequencies for each area ofthe plurality of areas of stimulation to avoid simultaneous delivery ofpulses of the neurostimulation pulses in response to a selection of themultiple frequency mode.
 3. The system of claim 2, wherein thestimulation frequency module is configured to identify one or morecompatible frequencies for each area of the plurality of areas ofstimulation from a plurality of predetermined stimulation frequencies toavoid simultaneous delivery of pulses of the neurostimulation pulses,and to indicate the identified one or more compatible frequencies in thestimulation rate table.
 4. The system of claim 3, wherein thestimulation frequency module is configured to present the plurality ofstimulation frequencies with visual indications for the identified oneor more compatible frequencies in the stimulation rate table.
 5. Thesystem of claim 4, wherein the stimulation frequency module isconfigured to allow a selection of a stimulation frequency only from theidentified one or more compatible frequencies.
 6. The system of claim 4,wherein the stimulation frequency module is configured to perform anarbitration for each stimulation frequency of the plurality ofstimulation frequencies that is not identified as one of the one or morecompatible frequencies, the arbitration modifying a time of delivery ofeach neurostimulation pulse associated with that stimulation frequencyto avoid the simultaneous delivery of pulses of the neurostimulationpulses.
 7. The system of claim 6, wherein the stimulation frequencymodule is configured to present the plurality of stimulation frequencieswith visual indications for one or more of stimulation frequencies ofthe plurality of stimulation frequencies to which the arbitration isperformed or a degree to which the arbitration is performed for thesestimulation frequencies.
 8. The system of claim 1, wherein the userinterface comprises a graphical user interface.
 9. The system of claim1, comprising: an implantable stimulator including: a stimulation outputcircuit configured to deliver the neurostimulation pulses; and astimulation control circuit configured to control the delivery of theneurostimulation pulses using the plurality of stimulation parameters;and an external programming device configured to be communicativelycoupled to the implantable stimulator via a wireless communication link,the external programming device including the programming controlcircuit and the user interface.
 10. A method for deliveringneurostimulation to a patient using a plurality of electrodes, themethod comprising: displaying a stimulation rate table on a displayscreen of a user interface, the stimulation rate table presenting aplurality of stimulation frequencies associated with each area of aplurality of areas of stimulation each defined by a set of electrodesselected from the plurality of electrodes; receiving a selection of astimulation frequency from the presented plurality of stimulationfrequencies for each area of the plurality of areas of stimulation;generating a plurality of stimulation parameters controlling delivery ofneurostimulation pulses using the stimulation frequencies selected forthe plurality of areas of stimulation; and allowing the user to selectbetween a single frequency mode and a multiple frequency mode using theuser interface, the single frequency mode allowing for adjustment of thestimulation frequency for an area of the plurality of areas ofstimulation with adjustment of the stimulation frequency for anotherarea of the plurality of areas of stimulation, the multiple frequencymode allowing for adjustment of the stimulation frequency for an area ofthe plurality of areas of stimulation without adjustment of thestimulation frequency for another area of the plurality of areas ofstimulation.
 11. The method of claim 10, further comprising computingcompatible frequencies for each area of the plurality of areas ofstimulation to avoid simultaneous delivery of pulses of theneurostimulation pulses in response to a selection of the multiplefrequency mode.
 12. The method of claim 11, comprising: identifying oneor more compatible frequencies for each area of the plurality of areasof stimulation from a plurality of predetermined stimulation frequenciesto avoid simultaneous delivery of pulses of the neurostimulation pulses;and indicating the identified one or more compatible frequencies in thestimulation rate table.
 13. The method of claim 12, wherein displayingthe stimulation rate table comprises presenting the plurality ofstimulation frequencies with visual indications for the identified oneor more compatible frequencies.
 14. The method of claim 13, furthercomprising allowing a selection of a stimulation frequency only from theidentified one or more compatible frequencies.
 15. The method of claim13, further comprising performing an arbitration for each stimulationfrequency of the plurality of stimulation frequencies that is notidentified as one of the one or more compatible frequencies, thearbitration modifying a time of delivery of each neurostimulation pulseassociated with that stimulation frequency to avoid the simultaneousdelivery of pulses of the neurostimulation pulses.
 16. The method ofclaim 15, wherein displaying the stimulation rate table comprisespresenting the plurality of stimulation frequencies with visualindications for each stimulation frequency to which the arbitration isperformed.
 17. The method of claim 10, wherein generating the pluralityof stimulation parameters comprises: defining the plurality of areas ofstimulation using the user interface; composing one or more stimulationwaveforms associated with the plurality of areas of stimulation usingthe user interface; and generating the plurality of stimulationparameters based on the one or more stimulation waveforms.
 18. Themethod of claim 17, further comprising transmitting the plurality ofstimulation parameters to an implantable stimulator via a wirelesscommunication link, the implantable stimulator coupled to one or moreimplantable lead including lead electrodes of the plurality ofelectrodes.
 19. A non-transitory computer-readable storage mediumincluding instructions, which when executed by a system, cause thesystem to: display a stimulation rate table on a display screen of auser interface, the stimulation rate table presenting a plurality ofstimulation frequencies associated with each area of a plurality ofareas of stimulation each defined by a set of electrodes selected fromthe plurality of electrodes; receive a selection of a stimulationfrequency from the presented plurality of stimulation frequencies foreach area of the plurality of areas of stimulation; generate a pluralityof stimulation parameters controlling delivery of neurostimulationpulses using the stimulation frequencies selected for the plurality ofareas of stimulation; and allow the user to select between a singlefrequency mode and a multiple frequency mode using the user interface,the single frequency mode allowing for adjustment of the stimulationfrequency for an area of the plurality of areas of stimulation withadjustment of the stimulation frequency for another area of theplurality of areas of stimulation, the multiple frequency mode allowingfor adjustment of the stimulation frequency for an area of the pluralityof areas of stimulation without adjustment of the stimulation frequencyfor another area of the plurality of areas of stimulation.
 20. Thenon-transitory computer-readable storage medium of claim 19, wherein theinstructions, when executed by the system, cause the system to computecompatible frequencies for each area of the plurality of areas ofstimulation to avoid simultaneous delivery of pulses of theneurostimulation pulses in response to a selection of the multiplefrequency mode.